cannabidiol

• Withdrawal due to adverse events

  increases

  Withdrawal due to adverse events was also higher in CBD groups compared with placebo (OR 2.65, 95% CI: 1.04–6.80)

  PMID:32268347 · one of two readings recorded this

• abnormal liver function tests, odds ratio CBD vs placebo

  increases, OR 11.19 (95% CI 2.09-60.02)

  Not recorded as a finding: The threshold (>3 times upper limit of normal) is stated in a separate sentence, so the quote does not meet the hepatotoxicity-incidence definition on its own

  There was an increased OR for abnormal liver function tests (OR 11.19, 95% CI: 2.09–60.02), with all 21 events occurring in the CBD groups compared with no events in patients treated with placebo.

  PMID:32268347 · one of two readings recorded this

• abnormal liver function tests (transaminase above 3 times upper limit of normal), pooled OR

  increases, OR 11.19 (95% CI 2.09-60.02)

  Not recorded as a finding: The hepatotoxicity-incidence node requires an adjudicated injury event; the paper reports a laboratory cut-off count from three childhood epilepsy trials.

  There was an increased OR for abnormal liver function tests (OR 11.19, 95% CI: 2.09–60.02), with all 21 events occurring in the CBD groups compared with no events in patients treated with placebo.

  PMID:32268347 · one of two readings recorded this

• Adverse event: decreased appetite, epilepsy studies

  increases

  decreased appetite (OR 4.12, 95% CI: 2.16–7.85)

  PMID:32268347 · one of two readings recorded this

• Adverse event: decreased appetite

  increases

  decreased appetite (OR 3.56, 95% CI: 1.94–6.53)

  PMID:32268347 · one of two readings recorded this

• Adverse event: diarrhoea, epilepsy studies

  increases

  diarrhoea (OR 2.18, 95% CI: 1.09–4.33)

  PMID:32268347 · one of two readings recorded this

• Adverse event: diarrhoea, non-epilepsy studies

  increases

  diarrhoea (OR 5.03, 95% CI: 1.44–17.61)

  PMID:32268347 · one of two readings recorded this

• Adverse event: diarrhoea

  increases

  diarrhoea (OR 2.61, 95% CI: 1.46–4.67)

  PMID:32268347 · one of two readings recorded this

• Adverse event: sedation, epilepsy studies

  no effect, p = 0.07

  Sedation (OR 4.10, 95% CI: 0.89–18.91) was not statistically different from placebo (p = 0.07)

  PMID:32268347 · one of two readings recorded this

• Adverse event: sedation

  increases

  sedation (OR 4.21, 95% CI: 1.18–15.01)

  PMID:32268347 · one of two readings recorded this

• Adverse event: somnolence, epilepsy studies

  increases

  somnolence (OR 3.00, 95% CI: 1.60–5.61)

  PMID:32268347 · one of two readings recorded this

• Adverse event: somnolence

  increases

  somnolence (OR 2.23, 95% CI: 1.07–4.64)

  PMID:32268347 · one of two readings recorded this

• adverse events due to pneumonia, decreased appetite, diarrhoea, somnolence and sedation, odds ratios

  increases, decreased appetite OR 3.56 (95% CI 1.94-6.53); diarrhoea OR 2.61 (95% CI 1.46-4.67)

  Not recorded as a finding: No outcome nodes for these specific adverse events

  CBD was also associated with a greater OR for decreased appetite (OR 3.56, 95% CI: 1.94–6.53), diarrhoea (OR 2.61, 95% CI: 1.46–4.67), sedation (OR 4.21, 95% CI: 1.18–15.01) and somnolence (OR 2.23, 95% CI: 1.07–4.64).

  PMID:32268347 · one of two readings recorded this

• Any adverse event, CBD dose meta-regression

  increases, p = 0.0023

  Here, the results of dosage meta-regression were highly significant (β = 0.0013, p = 0.0023)

  PMID:32268347 · one of two readings recorded this

• Any adverse event, epilepsy studies

  increases

  In the five studies involving children with epilepsy, 67.8% of those given CBD had adverse events, compared with 51.5% on placebo (OR 1.92, 95% CI: 1.33–2.78)

  PMID:32268347 · one of two readings recorded this

• Any adverse event, non-epilepsy studies

  no effect

  whereas in the five non-epilepsy studies the rates were similar: 67.0% and 62.2%, respectively (OR 0.85, 95% CI: 0.42–1.70)

  PMID:32268347 · one of two readings recorded this

• any adverse event, odds ratio CBD vs placebo

  increases, OR 1.55 (95% CI 1.03-2.33)

  Not recorded as a finding: No direction word in the sentence; node supplement-adverse-event-incidence also needs a participant-level proportion

  The OR for experiencing any adverse event with CBD compared with placebo was 1.55 (95% CI: 1.03–2.33).

  PMID:32268347 · one of two readings recorded this

• any adverse event, pooled OR CBD versus placebo

  increases, OR 1.55 (95% CI 1.03-2.33)

  Not recorded as a finding: The sentence carries the direction only as a signed OR, and the supplement-adverse-event-incidence node covers oral supplements rather than pharmaceutical trial drug.

  The OR for experiencing any adverse event with CBD compared with placebo was 1.55 (95% CI: 1.03–2.33).

  PMID:32268347 · one of two readings recorded this

• Any adverse event

  increases

  The OR for experiencing any adverse event with CBD compared with placebo was 1.55 (95% CI: 1.03–2.33)

  PMID:32268347 · one of two readings recorded this

• any serious adverse event, odds ratio CBD vs placebo

  increases, OR 2.30 (95% CI 1.18-4.48); 61/415 CBD vs 18/295 placebo

  Not recorded as a finding: The sentence gives counts and an odds ratio but no direction word, so direction would rest on a signed estimate

  There were 61 serious adverse events in 415 participants in the CBD arms (14.7%), compared with 18 among 295 participants in the placebo arms (6.1%), an OR of 2.30 (95% CI: 1.18–4.48).

  PMID:32268347 · one of two readings recorded this

• any serious adverse event, pooled OR CBD versus placebo

  increases, OR 2.30 (95% CI 1.18-4.48); 14.7% versus 6.1%

  Not recorded as a finding: The sentence reports event counts and an OR with no direction word, so direction would rest on the signed estimate alone.

  There were 61 serious adverse events in 415 participants in the CBD arms (14.7%), compared with 18 among 295 participants in the placebo arms (6.1%), an OR of 2.30 (95% CI: 1.18–4.48).

  PMID:32268347 · one of two readings recorded this

• Proportion with any adverse event

  increases

  In total, 67.6% of CBD-treated participants reported an adverse event, compared with 54.5% of those treated with placebo

  PMID:32268347 · one of two readings recorded this

• Proportion withdrawing for any reason, high dose

  At high doses (1400–3000 mg) 12.9% (35/272) of participants withdrew, compared with 8.8% (14/160) at medium doses (600–1000 mg), and only 4.3% (2/46) at low doses (20–400 mg), a similar rate to placebo (3.5% [12/344])

  PMID:32268347 · one of two readings recorded this

• Proportion withdrawing for any reason, low dose

  At high doses (1400–3000 mg) 12.9% (35/272) of participants withdrew, compared with 8.8% (14/160) at medium doses (600–1000 mg), and only 4.3% (2/46) at low doses (20–400 mg), a similar rate to placebo (3.5% [12/344])

  PMID:32268347 · one of two readings recorded this

• Proportion withdrawing for any reason, medium dose

  At high doses (1400–3000 mg) 12.9% (35/272) of participants withdrew, compared with 8.8% (14/160) at medium doses (600–1000 mg), and only 4.3% (2/46) at low doses (20–400 mg), a similar rate to placebo (3.5% [12/344])

  PMID:32268347 · one of two readings recorded this

• Proportion withdrawing for any reason, placebo

  At high doses (1400–3000 mg) 12.9% (35/272) of participants withdrew, compared with 8.8% (14/160) at medium doses (600–1000 mg), and only 4.3% (2/46) at low doses (20–400 mg), a similar rate to placebo (3.5% [12/344])

  PMID:32268347 · one of two readings recorded this

• Serious adverse event: abnormal liver function tests

  increases

  There was an increased OR for abnormal liver function tests (OR 11.19, 95% CI: 2.09–60.02), with all 21 events occurring in the CBD groups compared with no events in patients treated with placebo

  PMID:32268347 · one of two readings recorded this

• Serious adverse event: pneumonia

  increases

  There was an increased OR for pneumonia (OR 5.37, 95% CI: 1.17–24.65)

  PMID:32268347 · one of two readings recorded this

• Serious adverse events, CBD dose meta-regression

  no effect, p = 0.169

  The result of the dosage meta-regression was not significant (p = 0.169)

  PMID:32268347 · one of two readings recorded this

• Serious adverse events, epilepsy studies

  increases

  In epilepsy studies the OR was 2.70 (95% CI: 1.47–4.94)

  PMID:32268347 · one of two readings recorded this

• Serious adverse events, non-epilepsy studies

  no effect

  in non-epilepsy studies it was 0.34 (95% CI: 0.03–3.38)

  PMID:32268347 · one of two readings recorded this

• Serious adverse events

  increases

  There were 61 serious adverse events in 415 participants in the CBD arms (14.7%), compared with 18 among 295 participants in the placebo arms (6.1%), an OR of 2.30 (95% CI: 1.18–4.48)

  PMID:32268347 · one of two readings recorded this

• Withdrawal due to adverse events, CBD dose meta-regression

  no effect, p = 0.274

  although there was no significant correlation with CBD dose in the meta-regression (β = 0.0014; p = 0.274)

  PMID:32268347 · one of two readings recorded this

• Withdrawal due to adverse events, epilepsy studies

  increases

  and withdrawal due to adverse events (OR 3.91, 95% CI: 1.32–11.62)

  PMID:32268347 · one of two readings recorded this

• Withdrawal due to adverse events, non-epilepsy studies

  no effect

  or adverse events (OR 0.84, 95% CI: 0.13–5.46)

  PMID:32268347 · one of two readings recorded this

• Withdrawal for any reason, CBD dose meta-regression

  unclear, p = 0.077

  Meta-regressions indicated that there was a trend for an effect of CBD dose on withdrawal (β = 0.0014; p = 0.077)

  PMID:32268347 · one of two readings recorded this

• Withdrawal for any reason, epilepsy studies

  increases

  there was an increased odds of withdrawal due to any reason (OR 3.71, 95% CI: 1.60–8.64)

  PMID:32268347 · one of two readings recorded this

• Withdrawal for any reason, non-epilepsy studies

  no effect

  in non-epilepsy studies withdrawal due to any reason (OR 1.62, 95% CI: 0.61–4.34)

  PMID:32268347 · one of two readings recorded this

• Withdrawal for any reason

  increases

  Across all doses, there were more withdrawals due to any reason (OR 2.61, 95% CI: 1.38–4.96) in CBD groups compared with placebo

  PMID:32268347 · one of two readings recorded this

• 50% responder rate, combined doses (odds ratio)

  increases, p = 0.0001

  the odds ratios (95% CIs) were 2.51 (1.69, 3.71; P <.0001) with CLB

  PMID:32592183 · one of two readings recorded this

• 50% responder rate, combined doses (odds ratio)

  increases, p = 0.002

  2.40 (1.38, 4.16; P =.0020) without CLB

  PMID:32592183 · one of two readings recorded this

• 50% responder rate, GWEP1332B (DS), CBD 20 mg/kg/day vs placebo

  unclear, p = 0.0784

  Efficacy: 50% responder rates | Placebo: 14.5% CBD 10 mg/kg/day: 35.6%, P =.0030 CBD 20 mg/kg/day: 39.5%, P =.0006 | Placebo: 23.5% CBD 20 mg/kg/day: 44.2%, P =.0043 | Placebo: 27.1% CBD 20 mg/kg/day: 42.6%, P =.0784 | Placebo: 26.2% CBD 10 mg/kg/day: 43.9%, P =.0332 CBD 20 mg/kg/day: 49.3%, P =.0069

  PMID:32592183 · one of two readings recorded this

• 50% responder rate, GWEP1414 (LGS), CBD 10 mg/kg/day vs placebo

  increases, p = 0.003

  Efficacy: 50% responder rates | Placebo: 14.5% CBD 10 mg/kg/day: 35.6%, P =.0030 CBD 20 mg/kg/day: 39.5%, P =.0006 | Placebo: 23.5% CBD 20 mg/kg/day: 44.2%, P =.0043 | Placebo: 27.1% CBD 20 mg/kg/day: 42.6%, P =.0784 | Placebo: 26.2% CBD 10 mg/kg/day: 43.9%, P =.0332 CBD 20 mg/kg/day: 49.3%, P =.0069

  PMID:32592183 · one of two readings recorded this

• 50% responder rate, GWEP1414 (LGS), CBD 20 mg/kg/day vs placebo

  increases, p = 0.0006

  Efficacy: 50% responder rates | Placebo: 14.5% CBD 10 mg/kg/day: 35.6%, P =.0030 CBD 20 mg/kg/day: 39.5%, P =.0006 | Placebo: 23.5% CBD 20 mg/kg/day: 44.2%, P =.0043 | Placebo: 27.1% CBD 20 mg/kg/day: 42.6%, P =.0784 | Placebo: 26.2% CBD 10 mg/kg/day: 43.9%, P =.0332 CBD 20 mg/kg/day: 49.3%, P =.0069

  PMID:32592183 · one of two readings recorded this

• 50% responder rate, GWEP1423 (LGS), CBD 20 mg/kg/day vs placebo

  increases, p = 0.0043

  Efficacy: 50% responder rates | Placebo: 14.5% CBD 10 mg/kg/day: 35.6%, P =.0030 CBD 20 mg/kg/day: 39.5%, P =.0006 | Placebo: 23.5% CBD 20 mg/kg/day: 44.2%, P =.0043 | Placebo: 27.1% CBD 20 mg/kg/day: 42.6%, P =.0784 | Placebo: 26.2% CBD 10 mg/kg/day: 43.9%, P =.0332 CBD 20 mg/kg/day: 49.3%, P =.0069

  PMID:32592183 · one of two readings recorded this

• 50% responder rate, GWEP1424 (DS), CBD 10 mg/kg/day vs placebo

  increases, p = 0.0332

  Efficacy: 50% responder rates | Placebo: 14.5% CBD 10 mg/kg/day: 35.6%, P =.0030 CBD 20 mg/kg/day: 39.5%, P =.0006 | Placebo: 23.5% CBD 20 mg/kg/day: 44.2%, P =.0043 | Placebo: 27.1% CBD 20 mg/kg/day: 42.6%, P =.0784 | Placebo: 26.2% CBD 10 mg/kg/day: 43.9%, P =.0332 CBD 20 mg/kg/day: 49.3%, P =.0069

  PMID:32592183 · one of two readings recorded this

• 50% responder rate, GWEP1424 (DS), CBD 20 mg/kg/day vs placebo

  increases, p = 0.0069

  Efficacy: 50% responder rates | Placebo: 14.5% CBD 10 mg/kg/day: 35.6%, P =.0030 CBD 20 mg/kg/day: 39.5%, P =.0006 | Placebo: 23.5% CBD 20 mg/kg/day: 44.2%, P =.0043 | Placebo: 27.1% CBD 20 mg/kg/day: 42.6%, P =.0784 | Placebo: 26.2% CBD 10 mg/kg/day: 43.9%, P =.0332 CBD 20 mg/kg/day: 49.3%, P =.0069

  PMID:32592183 · one of two readings recorded this

• 50% responder rate (odds ratio)

  unclear

  odds ratio [95% CI], 1.51 [0.36, 6.41]

  PMID:32592183 · one of two readings recorded this

• Baseline seizure frequency per 28 days, by clobazam use

  Patients treated without CLB also had a higher baseline frequency of seizures per 28 days than patients with CLB (54 without and 36 with CLB)

  PMID:32592183 · one of two readings recorded this

• Change in seizure frequency, combined doses (treatment ratio)

  decreases, p = 0.0001

  the treatment ratios (95% CIs) were 0.59 (0.52, 0.68; P <.0001) with CLB

  PMID:32592183 · one of two readings recorded this

• Change in seizure frequency, combined doses (treatment ratio)

  decreases, p = 0.0226

  0.85 (0.73, 0.98; P =.0226) without CLB

  PMID:32592183 · one of two readings recorded this

• Change in seizure frequency (treatment ratio)

  unclear

  treatment ratio [95% CI], 0.81 [0.57, 1.17]

  PMID:32592183 · one of two readings recorded this

• Exposure-response: CBD plasma AUC and probability of at least 50% reduction in drop seizures

  increases, p = 0.01

  There was a positive correlation (P <.01) between the derived area under the curve of CBD in plasma and the probability of a ≥ 50% response

  PMID:32592183 · one of two readings recorded this

• percentage change in primary seizure frequency, treatment ratio by negative binomial regression

  decreases

  Not recorded as a finding: No outcome node for seizure frequency reduction

  The results of the meta‐analysis for the negative binomial regression on the change in seizure frequency, the primary endpoint in all four trials, favored CBD vs. placebo, regardless of CLB co‐therapy.

  PMID:32592183 · one of two readings recorded this

• percentage change in seizure frequency (primary seizure type), treatment ratio by negative binomial regression

  decreases, treatment ratio 0.59 (0.52, 0.68) with clobazam; 0.85 (0.73, 0.98) without clobazam

  Not recorded as a finding: No outcome node for change in seizure frequency as a treatment ratio.

  For the principal combined CBD dose vs. placebo analysis, the treatment ratios (95% CIs) were 0.59 (0.52, 0.68; P <.0001) with CLB and 0.85 (0.73, 0.98; P =.0226) without CLB.

  PMID:32592183 · one of two readings recorded this

• Percentage reduction in seizure frequency, GWEP1332B (DS), CBD 20 mg/kg/day vs placebo

  decreases, p = 0.0123

  Efficacy: reduction in seizure frequency | Placebo: 17.2% CBD 10 mg/kg/day: 37.2%, P =.0016 CBD 20 mg/kg/day: 41.9%, P =.0047 | Placebo: 21.8% CBD 20 mg/kg/day: 43.9%, P =.0135 | Placebo: 13.3% CBD 20 mg/kg/day: 38.9%, P =.0123 | Placebo: 26.9% CBD 10 mg/kg/day: 48.7%, P =.0095 CBD 20 mg/kg/day: 45.7%, P =.0299

  PMID:32592183 · one of two readings recorded this

• Percentage reduction in seizure frequency, GWEP1414 (LGS), CBD 10 mg/kg/day vs placebo

  decreases, p = 0.0016

  Efficacy: reduction in seizure frequency | Placebo: 17.2% CBD 10 mg/kg/day: 37.2%, P =.0016 CBD 20 mg/kg/day: 41.9%, P =.0047 | Placebo: 21.8% CBD 20 mg/kg/day: 43.9%, P =.0135 | Placebo: 13.3% CBD 20 mg/kg/day: 38.9%, P =.0123 | Placebo: 26.9% CBD 10 mg/kg/day: 48.7%, P =.0095 CBD 20 mg/kg/day: 45.7%, P =.0299

  PMID:32592183 · one of two readings recorded this

• Percentage reduction in seizure frequency, GWEP1414 (LGS), CBD 20 mg/kg/day vs placebo

  decreases, p = 0.0047

  Efficacy: reduction in seizure frequency | Placebo: 17.2% CBD 10 mg/kg/day: 37.2%, P =.0016 CBD 20 mg/kg/day: 41.9%, P =.0047 | Placebo: 21.8% CBD 20 mg/kg/day: 43.9%, P =.0135 | Placebo: 13.3% CBD 20 mg/kg/day: 38.9%, P =.0123 | Placebo: 26.9% CBD 10 mg/kg/day: 48.7%, P =.0095 CBD 20 mg/kg/day: 45.7%, P =.0299

  PMID:32592183 · one of two readings recorded this

• Percentage reduction in seizure frequency, GWEP1423 (LGS), CBD 20 mg/kg/day vs placebo

  decreases, p = 0.0135

  Efficacy: reduction in seizure frequency | Placebo: 17.2% CBD 10 mg/kg/day: 37.2%, P =.0016 CBD 20 mg/kg/day: 41.9%, P =.0047 | Placebo: 21.8% CBD 20 mg/kg/day: 43.9%, P =.0135 | Placebo: 13.3% CBD 20 mg/kg/day: 38.9%, P =.0123 | Placebo: 26.9% CBD 10 mg/kg/day: 48.7%, P =.0095 CBD 20 mg/kg/day: 45.7%, P =.0299

  PMID:32592183 · one of two readings recorded this

• Percentage reduction in seizure frequency, GWEP1424 (DS), CBD 10 mg/kg/day vs placebo

  decreases, p = 0.0095

  Efficacy: reduction in seizure frequency | Placebo: 17.2% CBD 10 mg/kg/day: 37.2%, P =.0016 CBD 20 mg/kg/day: 41.9%, P =.0047 | Placebo: 21.8% CBD 20 mg/kg/day: 43.9%, P =.0135 | Placebo: 13.3% CBD 20 mg/kg/day: 38.9%, P =.0123 | Placebo: 26.9% CBD 10 mg/kg/day: 48.7%, P =.0095 CBD 20 mg/kg/day: 45.7%, P =.0299

  PMID:32592183 · one of two readings recorded this

• Percentage reduction in seizure frequency, GWEP1424 (DS), CBD 20 mg/kg/day vs placebo

  decreases, p = 0.0299

  Efficacy: reduction in seizure frequency | Placebo: 17.2% CBD 10 mg/kg/day: 37.2%, P =.0016 CBD 20 mg/kg/day: 41.9%, P =.0047 | Placebo: 21.8% CBD 20 mg/kg/day: 43.9%, P =.0135 | Placebo: 13.3% CBD 20 mg/kg/day: 38.9%, P =.0123 | Placebo: 26.9% CBD 10 mg/kg/day: 48.7%, P =.0095 CBD 20 mg/kg/day: 45.7%, P =.0299

  PMID:32592183 · one of two readings recorded this

• Proportion of CBD patients with any clobazam dose adjustment

  20.4% of CBD patients had any CLB dose adjustments

  PMID:32592183 · one of two readings recorded this

• Proportion who had tried and discontinued at least six ASDs, by clobazam use

  A higher proportion of patients not taking concomitant CLB had tried and discontinued at least six ASDs compared with patients currently taking CLB (54.7% without and 28.6% with CLB)

  PMID:32592183 · one of two readings recorded this

• >=50% responder odds ratio in Lennox-Gastaut syndrome

  increases, OR 3.14 (2.04-4.81) overall; 3.48 (1.96-6.17) on clobazam

  Not recorded as a finding: The only sentence reporting it does not name CBD; it refers to 'this effect'

  This effect was also reflected in the ≥50% responder odds ratios (overall population, 3.14 [2.04‐4.81], p < 0.0001; patients on clobazam, 3.48 [1.96‐6.17], p < 0.0001).

  PMID:32969022 · one of two readings recorded this

• ALT increased TEAE, patients n

  increases

  ALT increased | 3 (2) | 3 (5) | 12 (7) | 1 (1) | 3 (9) | 5 (6) | 0 | 3 (4) | 9 (7) | 0 | 2 (4) | 6 (7)

  PMID:32969022 · one of two readings recorded this

• AST increased TEAE, patients n

  increases

  AST increased | 2 (1) | 2 (3) | 9 (5) | 1 (1) | 2 (6) | 4 (5) | 0 | 3 (4) | 11 (8) | 0 | 3 (6) | 10 (11)

  PMID:32969022 · one of two readings recorded this

• At least 50% responder rate, DS (odds ratio)

  increases, p = 0.0001

  Meta‐analysis | CBD10 + CBD20 | 0.8512 | 2.34 (1.51‐3.63) | 0.0001 | 0.8763 | 2.78 (1.62‐4.77) | 0.0002

  PMID:32969022 · one of two readings recorded this

• At least 50% responder rate, DS (odds ratio)

  increases, p = 0.0346

  GWPCARE2 | CBD10 | 2.24 (1.06‐4.73) | 0.0346 | 0.9722 | 2.33 (0.96‐5.68) | 0.0623

  PMID:32969022 · one of two readings recorded this

• At least 50% responder rate, DS (odds ratio)

  unclear, p = 0.0768

  GWPCARE1 | CBD20 | 2.04 (0.93‐4.51) | 0.0768 | 0.2517 | 2.88 (1.06‐7.84) | 0.0382

  PMID:32969022 · one of two readings recorded this

• At least 50% responder rate, DS (odds ratio)

  increases, p = 0.0073

  CBD20 | 2.77 (1.32‐5.82) | 0.0073 | 0.8188 | 3.26 (1.28‐8.26) | 0.0130

  PMID:32969022 · one of two readings recorded this

• At least 50% responder rate, DS (odds ratio)

  increases, p = 0.0015

  CBD20 | 0.5837 | 2.40 (1.40‐4.13) | 0.0015 | 0.8612 | 3.08 (1.56‐6.08) | 0.0012

  PMID:32969022 · one of two readings recorded this

• At least 50% responder rate, DS (odds ratio)

  increases, p = 0.0002

  Meta‐analysis | CBD10 + CBD20 | 0.8512 | 2.34 (1.51‐3.63) | 0.0001 | 0.8763 | 2.78 (1.62‐4.77) | 0.0002

  PMID:32969022 · one of two readings recorded this

• At least 50% responder rate, DS (odds ratio)

  unclear, p = 0.0623

  GWPCARE2 | CBD10 | 2.24 (1.06‐4.73) | 0.0346 | 0.9722 | 2.33 (0.96‐5.68) | 0.0623

  PMID:32969022 · one of two readings recorded this

• At least 50% responder rate, DS (odds ratio)

  increases, p = 0.0382

  GWPCARE1 | CBD20 | 2.04 (0.93‐4.51) | 0.0768 | 0.2517 | 2.88 (1.06‐7.84) | 0.0382

  PMID:32969022 · one of two readings recorded this

• At least 50% responder rate, DS (odds ratio)

  increases, p = 0.013

  CBD20 | 2.77 (1.32‐5.82) | 0.0073 | 0.8188 | 3.26 (1.28‐8.26) | 0.0130

  PMID:32969022 · one of two readings recorded this

• At least 50% responder rate, DS (odds ratio)

  increases, p = 0.0012

  CBD20 | 0.5837 | 2.40 (1.40‐4.13) | 0.0015 | 0.8612 | 3.08 (1.56‐6.08) | 0.0012

  PMID:32969022 · one of two readings recorded this

• At least 50% responder rate, LGS (odds ratio)

  increases, p = 0.0001

  Meta‐analysis | CBD10 + CBD20 | 0.7482 | 3.14 (2.04‐4.81) | <0.0001 | 0.6720 | 3.48 (1.96‐6.17) | <0.0001

  PMID:32969022 · one of two readings recorded this

• At least 50% responder rate, LGS (odds ratio)

  increases, p = 0.0035

  GWPCARE3 | CBD10 | 3.30 (1.48‐7.35) | 0.0035 | 0.5021 | 2.72 (0.96‐7.67) | 0.0584

  PMID:32969022 · one of two readings recorded this

• At least 50% responder rate, LGS (odds ratio)

  increases, p = 0.0008

  CBD20 | 3.87 (1.76‐8.53) | 0.0008 | 0.7015 | 5.12 (1.81‐14.54) | 0.0021

  PMID:32969022 · one of two readings recorded this

• At least 50% responder rate, LGS (odds ratio)

  increases, p = 0.0044

  GWPCARE4 | CBD20 | 2.61 (1.35‐5.06) | 0.0044 | 0.6190 | 3.14 (1.26‐7.81) | 0.0140

  PMID:32969022 · one of two readings recorded this

• At least 50% responder rate, LGS (odds ratio)

  increases, p = 0.0001

  CBD20 | 0.4545 | 3.07 (1.85‐5.10) | <0.0001 | 0.4879 | 3.88 (1.95‐7.71) | <0.0001

  PMID:32969022 · one of two readings recorded this

• At least 50% responder rate, LGS (odds ratio)

  increases, p = 0.0001

  Meta‐analysis | CBD10 + CBD20 | 0.7482 | 3.14 (2.04‐4.81) | <0.0001 | 0.6720 | 3.48 (1.96‐6.17) | <0.0001

  PMID:32969022 · one of two readings recorded this

• At least 50% responder rate, LGS (odds ratio)

  unclear, p = 0.0584

  GWPCARE3 | CBD10 | 3.30 (1.48‐7.35) | 0.0035 | 0.5021 | 2.72 (0.96‐7.67) | 0.0584

  PMID:32969022 · one of two readings recorded this

• At least 50% responder rate, LGS (odds ratio)

  increases, p = 0.0021

  CBD20 | 3.87 (1.76‐8.53) | 0.0008 | 0.7015 | 5.12 (1.81‐14.54) | 0.0021

  PMID:32969022 · one of two readings recorded this

• At least 50% responder rate, LGS (odds ratio)

  increases, p = 0.014

  GWPCARE4 | CBD20 | 2.61 (1.35‐5.06) | 0.0044 | 0.6190 | 3.14 (1.26‐7.81) | 0.0140

  PMID:32969022 · one of two readings recorded this

• At least 50% responder rate, LGS (odds ratio)

  increases, p = 0.0001

  CBD20 | 0.4545 | 3.07 (1.85‐5.10) | <0.0001 | 0.4879 | 3.88 (1.95‐7.71) | <0.0001

  PMID:32969022 · one of two readings recorded this

• Baseline convulsive seizure frequency, DS

  The median baseline convulsive seizure frequency (per 28 days) for patients with DS was 15.5 for placebo, 13.5 for the CBD10 group, and 10.4 for the CBD20 group

  PMID:32969022 · one of two readings recorded this

• Baseline drop seizure frequency, LGS

  The median baseline drop seizure frequency (per 28 days) for patients with LGS was 79.0 for placebo, 86.9 for the CBD10 group, and 78.1 for the CBD20 group

  PMID:32969022 · one of two readings recorded this

• Decreased appetite TEAE, patients n

  increases

  Decreased appetite | 8 (5) | 11 (16) | 32 (19) | 4 (5) | 4 (11) | 10 (13) | 14 (11) | 12 (17) | 41 (30) | 8 (10) | 9 (18) | 30 (34)

  PMID:32969022 · one of two readings recorded this

• Diarrhea TEAE, patients n

  increases

  Diarrhea | 13 (8) | 7 (10) | 28 (17) | 7 (9) | 2 (6) | 9 (11) | 15 (12) | 11 (15) | 37 (27) | 9 (11) | 7 (14) | 22 (25)

  PMID:32969022 · one of two readings recorded this

• Fatigue TEAE, patients n

  increases

  Fatigue | 4 (3) | 5 (8) | 13 (8) | 0 | 5 (14) | 7 (9) | 11 (8) | 5 (7) | 28 (20) | 7 (8) | 4 (8) | 24 (27)

  PMID:32969022 · one of two readings recorded this

• primary seizure frequency reduction (drop seizures in LGS, convulsive seizures in DS), treatment ratio by negative binomial regression

  decreases, p = 0.0001

  Not recorded as a finding: No outcome node for percentage change in primary seizure frequency

  In the meta‐analysis of the overall population, CBD resulted in a greater reduction in drop seizures compared with placebo (treatment ratio 0.70 [95% confidence interval {CI}, 0.62‐0.80], p < 0.0001).

  PMID:32969022 · one of two readings recorded this

• Reduction in convulsive seizure frequency, DS (treatment ratio)

  decreases, p = 0.0001

  Meta‐analysis | CBD10 + CBD20 | 0.8808 | 0.71 (0.60‐0.83) | <0.0001 | 0.7490 | 0.63 (0.52‐0.77) | <0.0001

  PMID:32969022 · one of two readings recorded this

• Reduction in convulsive seizure frequency, DS (treatment ratio)

  decreases, p = 0.0095

  GWPCARE2 | CBD10 | 0.70 (0.54‐0.92) | 0.0095 | 0.1691 | 0.63 (0.46‐0.86) | 0.0042

  PMID:32969022 · one of two readings recorded this

• Reduction in convulsive seizure frequency, DS (treatment ratio)

  decreases, p = 0.0082

  GWPCARE1 | CBD20 | 0.67 (0.50‐0.90) | 0.0082 | 0.57 (0.40‐0.83) | 0.0032

  PMID:32969022 · one of two readings recorded this

• Reduction in convulsive seizure frequency, DS (treatment ratio)

  decreases, p = 0.0299

  CBD20 | 0.74 (0.57‐0.97) | 0.0299 | 0.5702 | 0.69 (0.50‐0.96) | 0.0297

  PMID:32969022 · one of two readings recorded this

• Reduction in convulsive seizure frequency, DS (treatment ratio)

  decreases, p = 0.0006

  CBD20 | 0.6170 | 0.71 (0.58‐0.86) | 0.0006 | 0.4490 | 0.64 (0.50‐0.81) | 0.0003

  PMID:32969022 · one of two readings recorded this

• Reduction in convulsive seizure frequency, DS (treatment ratio)

  decreases, p = 0.0001

  Meta‐analysis | CBD10 + CBD20 | 0.8808 | 0.71 (0.60‐0.83) | <0.0001 | 0.7490 | 0.63 (0.52‐0.77) | <0.0001

  PMID:32969022 · one of two readings recorded this

• Reduction in convulsive seizure frequency, DS (treatment ratio)

  decreases, p = 0.0042

  GWPCARE2 | CBD10 | 0.70 (0.54‐0.92) | 0.0095 | 0.1691 | 0.63 (0.46‐0.86) | 0.0042

  PMID:32969022 · one of two readings recorded this

• Reduction in convulsive seizure frequency, DS (treatment ratio)

  decreases, p = 0.0032

  GWPCARE1 | CBD20 | 0.67 (0.50‐0.90) | 0.0082 | 0.57 (0.40‐0.83) | 0.0032

  PMID:32969022 · one of two readings recorded this

• Reduction in convulsive seizure frequency, DS (treatment ratio)

  decreases, p = 0.0297

  CBD20 | 0.74 (0.57‐0.97) | 0.0299 | 0.5702 | 0.69 (0.50‐0.96) | 0.0297

  PMID:32969022 · one of two readings recorded this

• Reduction in convulsive seizure frequency, DS (treatment ratio)

  decreases, p = 0.0003

  CBD20 | 0.6170 | 0.71 (0.58‐0.86) | 0.0006 | 0.4490 | 0.64 (0.50‐0.81) | 0.0003

  PMID:32969022 · one of two readings recorded this

• reduction in convulsive seizure frequency (treatment ratio), Dravet syndrome overall population

  decreases, treatment ratio 0.71 [0.60-0.83]

  Not recorded as a finding: No outcome node for percentage reduction in primary seizure frequency by negative binomial treatment ratio; the sentence is the same one used for the responder claim.

  In the overall DS population, CBD resulted in a greater reduction in convulsive seizures (0.71 [0.60‐0.83], p < 0.0001) and higher ≥50% responder rates (2.34 [1.51‐3.63], p = 0.0001) compared with placebo.

  PMID:32969022 · one of two readings recorded this

• Reduction in drop seizure frequency, LGS (treatment ratio)

  decreases, p = 0.0001

  Meta‐analysis | CBD10 + CBD20 | 0.8244 | 0.70 (0.62‐0.80) | <0.0001 | 0.1948 | 0.56 (0.47‐0.67) | <0.0001

  PMID:32969022 · one of two readings recorded this

• Reduction in drop seizure frequency, LGS (treatment ratio)

  decreases, p = 0.0032

  GWPCARE3 | CBD10 | 0.71 (0.56‐0.89) | 0.0032 | 0.9727 | 0.70 (0.51‐0.98) | 0.0355

  PMID:32969022 · one of two readings recorded this

• Reduction in drop seizure frequency, LGS (treatment ratio)

  decreases, p = 0.0005

  CBD20 | 0.66 (0.53‐0.83) | 0.0005 | 0.0067 | 0.46 (0.33‐0.64) | <0.0001

  PMID:32969022 · one of two readings recorded this

• Reduction in drop seizure frequency, LGS (treatment ratio)

  decreases, p = 0.0036

  GWPCARE4 | CBD20 | 0.73 (0.59‐0.90) | 0.0036 | 0.0123 | 0.54 (0.40‐0.73) | <0.0001

  PMID:32969022 · one of two readings recorded this

• Reduction in drop seizure frequency, LGS (treatment ratio)

  decreases, p = 0.0001

  CBD20 | 0.5363 | 0.70 (0.60‐0.82) | <0.0001 | 0.4734 | 0.51 (0.41‐0.63) | <0.0001

  PMID:32969022 · one of two readings recorded this

• Reduction in drop seizure frequency, LGS (treatment ratio)

  decreases, p = 0.0001

  Meta‐analysis | CBD10 + CBD20 | 0.8244 | 0.70 (0.62‐0.80) | <0.0001 | 0.1948 | 0.56 (0.47‐0.67) | <0.0001

  PMID:32969022 · one of two readings recorded this

• Reduction in drop seizure frequency, LGS (treatment ratio)

  decreases, p = 0.0355

  GWPCARE3 | CBD10 | 0.71 (0.56‐0.89) | 0.0032 | 0.9727 | 0.70 (0.51‐0.98) | 0.0355

  PMID:32969022 · one of two readings recorded this

• Reduction in drop seizure frequency, LGS (treatment ratio)

  decreases, p = 0.0001

  CBD20 | 0.66 (0.53‐0.83) | 0.0005 | 0.0067 | 0.46 (0.33‐0.64) | <0.0001

  PMID:32969022 · one of two readings recorded this

• Reduction in drop seizure frequency, LGS (treatment ratio)

  decreases, p = 0.0001

  GWPCARE4 | CBD20 | 0.73 (0.59‐0.90) | 0.0036 | 0.0123 | 0.54 (0.40‐0.73) | <0.0001

  PMID:32969022 · one of two readings recorded this

• Reduction in drop seizure frequency, LGS (treatment ratio)

  decreases, p = 0.0001

  CBD20 | 0.5363 | 0.70 (0.60‐0.82) | <0.0001 | 0.4734 | 0.51 (0.41‐0.63) | <0.0001

  PMID:32969022 · one of two readings recorded this

• Sedation TEAE, patients n

  increases

  Sedation | 2 (1) | 2 (3) | 10 (6) | 1 (1) | 2 (6) | 9 (11) | 0 | 1 (1) | 6 (4) | 0 | 1 (2) | 5 (6)

  PMID:32969022 · one of two readings recorded this

• Serious TEAEs, patients n

  increases

  Serious TEAEs | 12 (8) | 13 (19) | 33 (20) | 6 (8) | 8 (23) | 18 (23) | 14 (11) | 15 (21) | 28 (20) | 9 (11) | 11 (22) | 20 (23)

  PMID:32969022 · one of two readings recorded this

• Somnolence TEAE, patients n

  increases

  Somnolence | 12 (8) | 14 (21) | 38 (23) | 8 (10) | 11 (31) | 24 (30) | 16 (12) | 19 (26) | 38 (27) | 13 (16) | 17 (34) | 31 (35)

  PMID:32969022 · one of two readings recorded this

• TEAEs leading to discontinuation, patients n

  increases

  TEAEs leading to discontinuation | 2 (1) | 1 (2) | 18 (11) | 0 | 1 (3) | 11 (14) | 1 (1) | 1 (1) | 15 (11) | 1 (1) | 0 | 10 (11)

  PMID:32969022 · one of two readings recorded this

• Treatment-emergent adverse events (TEAEs), patients n

  increases

  TEAEs | 114 (71) | 56 (84) | 151 (90) | 58 (73) | 31 (89) | 74 (94) | 108 (82) | 61 (85) | 126 (91) | 73 (87) | 44 (88) | 83 (94)

  PMID:32969022 · one of two readings recorded this

• absolute reduction in seizure frequency, risk difference

  increases, RD 0.31 (95% CI 0.18-0.44; I2 = 77%), n = 726

  Not recorded as a finding: No outcome node for seizure frequency reduction

  This analysis demonstrated increase in the number of patients who obtained absolute reduction in the frequency of seizures [risk difference (RD)=0.31 (95%CI 0.18–0.44; I2=77%)], NNT=3.

  PMID:36417631 · one of two readings recorded this

• Absolute reduction in seizures (risk difference)

  increases

  risk difference (RD)=0.31 (95%CI 0.18–0.44; I2=77%)

  PMID:36417631 · one of two readings recorded this

• Improvement in S/CGIC (risk difference)

  increases

  RD=0.21 (95%CI 0.14–0.28; I2=0%)

  PMID:36417631 · one of two readings recorded this

• Improvement of S/CGIC (risk ratio, GRADE table)

  increases, n = 726

  Improvement of clinical impression evaluated by patient or caregiver (S/CGIC) follow-up: range from 12–16 weeks | 726 (5 ECRs) | ⨁⨁⨁⨁ High | RR 1.54 (1.32 to 1.80) | 385 per 1,000 | 208 more per 1,000 (123 more to 308 more)

  PMID:36417631 · one of two readings recorded this

• Patients with absence of seizures (risk difference)

  increases

  RD=0.03 (95%CI 0.01–0.03; I2=44%)

  PMID:36417631 · one of two readings recorded this

• Patients with at least 50% reduction in seizures (risk difference)

  increases

  RD=0.20 (95%CI 0.13–0.26; I2=0%)

  PMID:36417631 · one of two readings recorded this

• Patients with at least 50% reduction in seizures (risk ratio, GRADE table)

  increases, n = 726

  Number of patients with a reduction equal to or greater than 50% in seizures follow-up: range 12–16 weeks | 726 (5 ECRs) | ⨁⨁⨁⨁ High | RR 1.88 (1.50 to 2.35) | 224 per 1,000 | 197 more per 1,000 (112 more to 303 more)

  PMID:36417631 · one of two readings recorded this

• Patients without seizures (risk ratio, GRADE table)

  increases, n = 726

  Number of patients without seizures follow-up: range 12–16 weeks | 726 (5 ECRs) | ⨁⨁⨁◯ Moderate b | RR 4.29 (1.24 to 14.87) | 6 per 1,000 | 18 more per 1,000 (1 more to 77 more)

  PMID:36417631 · one of two readings recorded this

• Severe adverse events (risk difference)

  increases

  RD=0.16 (95%CI 0.07–0.26; I2=72%)

  PMID:36417631 · one of two readings recorded this

• Severe adverse events (risk ratio, GRADE table)

  increases, n = 727

  Severe adverse events follow-up: range 12–16 weeks | 727 (5 ECRs) | ⨁⨁⨁◯ Moderate d | RR 3.25 (1.56 to 6.74) | 72 per 1,000 | 162 more per 1,000 (40 more to 413 more)

  PMID:36417631 · one of two readings recorded this

• Total adverse events (risk difference)

  increases

  RD=0.21 (95%CI 0.14–0.28; I2=83%)

  PMID:36417631 · one of two readings recorded this

• Total adverse events (risk ratio, GRADE table)

  increases, n = 733

  Total adverse events follow-up: range 4–16 weeks | 733 (5 ECRs) | ⨁'very Low b, c | RR 1.15 (1.00 to 1.32) | 801 per 1,000 | 120 more per 1,000 (0 less for 256 more)

  PMID:36417631 · one of two readings recorded this

• Transaminase elevation at least 3 times reference (risk difference)

  increases

  RD=0.15 (95%CI 0.05–0.24; I2=85%)

  PMID:36417631 · one of two readings recorded this

• Transaminase elevation at least 3 times reference (risk ratio, GRADE table)

  increases, n = 721

  Number of patients with transaminase elevation equal to or greater three times the follow-up reference: range 4–16 weeks | 721 (6 ECRs) | ⨁⨁’ Low | RR 11.20 (4.03 to 31.16) | 5 per 1,000 | 55 more per 1,000 (16 more to 164 more)

  PMID:36417631 · one of two readings recorded this

• transaminase elevation of 3 or more times the reference value, pooled RD

  increases, RD=0.15 (95%CI 0.05-0.24)

  Not recorded as a finding: The hepatotoxicity-incidence node requires an adjudicated injury event defined by the trial; the paper reports a laboratory threshold count only.

  This analysis demonstrated an increased risk of transaminase elevation ≥3 times the reference value in patients who received CBD, as compared to placebo [RD=0.15 (95%CI 0.05–0.24; I2=85%)], NNH=6.

  PMID:36417631 · one of two readings recorded this

• treatment abandonment (any reason), risk difference

  increases, RD 0.12 (95% CI 0.06-0.17; I2 = 50%), n = 741

  Not recorded as a finding: Node withdrawal-due-to-adverse-events requires an adverse-event reason; the paper counts abandonment of any cause

  CBD increased the risk of treatment abandonment in the patients who received CBD as compared to placebo [RD=0.12 (95%CI 0.06–0.17; I2=50%)], NNH=8.

  PMID:36417631 · one of two readings recorded this

• Treatment abandonment (risk difference)

  increases

  RD=0.12 (95%CI 0.06–0.17; I2=50%)

  PMID:36417631 · one of two readings recorded this

• treatment abandonment (risk), pooled across six RCTs

  increases, RD=0.12 (95%CI 0.06-0.17)

  Not recorded as a finding: The paper never states abandonment was due to adverse events, so the withdrawal-due-to-adverse-events node's required reason for discontinuation is not met.

  CBD increased the risk of treatment abandonment in the patients who received CBD as compared to placebo [RD=0.12 (95%CI 0.06–0.17; I2=50%)], NNH=8.

  PMID:36417631 · one of two readings recorded this

• Treatment abandonment (risk ratio, GRADE table)

  increases, n = 741

  Risk of treatment abandonment follow-up: range 4–16 weeks | 741 (6 ECRs) | ⨁⨁⨁⨁ High | RR 8.70 (3.80 to 19.89) | 14 per 1,000 | 105 more per 1,000 (38 more to 257 more)

  PMID:36417631 · one of two readings recorded this

• Adverse events leading to discontinuation

  increases

  (RR, 3.95; 95% CI, 1.86-8.37; I2 = 0.0%)

  PMID:37079302 · one of two readings recorded this

• adverse events resulting in dose reduction, pooled RR

  increases, RR 9.87 (95% CI 5.34-14.40)

  Not recorded as a finding: No outcome node for dose reduction due to adverse events

  The incidence of AEs that resulted in dose reduction in the 3 included studies was significantly higher in the CBD group than in the control group (RR, 9.87; 95% CI, 5.34-14.40; I2 = 0.0%) (eFigure 13 in Supplement 1).

  PMID:37079302 · one of two readings recorded this

• Adverse events resulting in dose reduction

  increases

  (RR, 9.87; 95% CI, 5.34-14.40; I2 = 0.0%)

  PMID:37079302 · one of two readings recorded this

• ALT or AST elevation (any grade)

  increases, p = 0.001

  ALT or AST elevation | 12.29 (4.22-35.80) | <.001

  PMID:37079302 · one of two readings recorded this

• Any grade adverse events

  increases

  1.12 (95% CI, 1.02-1.23; I2 = 58.9%) for any grade

  PMID:37079302 · one of two readings recorded this

• Any grade adverse events

  no effect

  1.15 (95% CI, 0.95-1.39; I2 = 33.6%) in studies with high risk of bias

  PMID:37079302 · one of two readings recorded this

• Any grade adverse events

  no effect

  1.05 (95% CI, 0.96-1.16; I2 = 62.9%) in studies with low risk of bias

  PMID:37079302 · one of two readings recorded this

• Any grade adverse events

  no effect

  1.35 (95% CI, 0.95-1.92; I2 = 12.8%) in studies with some concerns

  PMID:37079302 · one of two readings recorded this

• any grade and severe grade adverse events, pooled RR

  increases

  Not recorded as a finding: Sentence gives estimates without a direction word; node supplement-adverse-event-incidence defines a proportion of participants with at least one event, and the paper's percentages are of events

  The overall percentage of any grade AEs was higher in the CBD group than in the control group (9.7% vs 4.0%) (eFigure 1 in Supplement 1).

  PMID:37079302 · one of two readings recorded this

• Decreased appetite (any grade)

  increases, p = 0.001

  Decreased appetite | 2.13 (1.48-3.06) | <.001

  PMID:37079302 · one of two readings recorded this

• Diarrhea (any grade)

  increases, p = 0.001

  Diarrhea | 1.93 (1.44-2.58) | <.001

  PMID:37079302 · one of two readings recorded this

• Fatigue (any grade)

  no effect, p = 0.65

  Fatigue | 1.36 (0.36-5.16) c |.65

  PMID:37079302 · one of two readings recorded this

• incidence of serious adverse events, pooled RR CBD versus control (8 studies)

  increases, RR 2.67; 95% CI 1.83-3.88

  Not recorded as a finding: The only Results sentence carries the direction as a signed RR with no direction word, so it cannot be anchored.

  Using data from 8 of the included studies, the overall RR for the incidence of serious AEs in the CBD group compared with the control group was 2.67 (95% CI, 1.83-3.88; I2 = 8.9%).

  PMID:37079302 · one of two readings recorded this

• Mild grade diarrhea

  increases

  (RR, 1.71; 95% CI, 1.21-2.42; I2 = 0.0%)

  PMID:37079302 · one of two readings recorded this

• Moderate grade decreased appetite

  increases

  decreased appetite (RR, 3.25; 95% CI, 1.20-8.83; I2 = 0.0%)

  PMID:37079302 · one of two readings recorded this

• Moderate grade somnolence

  increases

  somnolence (RR, 3.62; 95% CI, 1.45-9.04; I2 = 0.0%)

  PMID:37079302 · one of two readings recorded this

• Nasopharyngitis (any grade)

  no effect, p = 0.92

  Nasopharyngitis | 1.02 (0.64-1.62) |.92

  PMID:37079302 · one of two readings recorded this

• Overall percentage of any grade adverse events

  increases

  The overall percentage of any grade AEs was higher in the CBD group than in the control group (9.7% vs 4.0%)

  PMID:37079302 · one of two readings recorded this

• Overall percentage of mild, moderate and severe adverse events: mild

  In the CBD arm, the overall percentages were 11.1% for mild AEs, 3.1% for moderate AEs, and 1.2% for severe AEs

  PMID:37079302 · one of two readings recorded this

• Overall percentage of mild, moderate and severe adverse events: mild

  In the control arm, the overall percentages were 6.4% for mild AEs, 1.3% for moderate AEs, and 0.7% for severe AEs

  PMID:37079302 · one of two readings recorded this

• Overall percentage of mild, moderate and severe adverse events: moderate

  In the CBD arm, the overall percentages were 11.1% for mild AEs, 3.1% for moderate AEs, and 1.2% for severe AEs

  PMID:37079302 · one of two readings recorded this

• Overall percentage of mild, moderate and severe adverse events: moderate

  In the control arm, the overall percentages were 6.4% for mild AEs, 1.3% for moderate AEs, and 0.7% for severe AEs

  PMID:37079302 · one of two readings recorded this

• Overall percentage of mild, moderate and severe adverse events: severe

  In the CBD arm, the overall percentages were 11.1% for mild AEs, 3.1% for moderate AEs, and 1.2% for severe AEs

  PMID:37079302 · one of two readings recorded this

• Overall percentage of mild, moderate and severe adverse events: severe

  In the control arm, the overall percentages were 6.4% for mild AEs, 1.3% for moderate AEs, and 0.7% for severe AEs

  PMID:37079302 · one of two readings recorded this

• Percentage of adverse events leading to trial discontinuation

  increases

  The percentage of AEs that led to the discontinuation of the trial was higher in the CBD arm than in the controls (2.4% vs 0.7%)

  PMID:37079302 · one of two readings recorded this

• Pneumonia (any grade)

  no effect, p = 0.18

  Pneumonia | 2.15 (0.69-6.68) |.18

  PMID:37079302 · one of two readings recorded this

• Pyrexia (any grade)

  no effect, p = 0.11

  Pyrexia | 1.32 (0.93-1.86) |.11

  PMID:37079302 · one of two readings recorded this

• Rash (any grade)

  unclear, p = 0.05

  Rash | 3.02 (1.00-9.14) |.05

  PMID:37079302 · one of two readings recorded this

• serious adverse events, pooled RR CBD vs control

  increases, RR 2.67 (95% CI 1.83-3.88; I2 = 8.9%)

  Not recorded as a finding: The sentence carries the direction only as a signed estimate (RR 2.67), with no direction word in the pooled sentence

  Using data from 8 of the included studies, the overall RR for the incidence of serious AEs in the CBD group compared with the control group was 2.67 (95% CI, 1.83-3.88; I2 = 8.9%).

  PMID:37079302 · one of two readings recorded this

• Serious adverse events

  increases

  the overall RR for the incidence of serious AEs in the CBD group compared with the control group was 2.67 (95% CI, 1.83-3.88; I2 = 8.9%)

  PMID:37079302 · one of two readings recorded this

• Severe grade adverse events

  increases

  3.39 (95% CI, 1.42-8.09; I2 = 3.5%) for severe grade

  PMID:37079302 · one of two readings recorded this

• Somnolence (any grade)

  increases, p = 0.001

  Somnolence | 2.29 (1.61-3.25) | <.001

  PMID:37079302 · one of two readings recorded this

• Status epilepticus (any grade)

  no effect, p = 0.75

  Status epilepticus | 0.91 (0.49-1.67) |.75

  PMID:37079302 · one of two readings recorded this

• Upper respiratory tract infection (any grade)

  no effect, p = 0.81

  Upper respiratory tract infection | 0.95 (0.60-1.49) |.81

  PMID:37079302 · one of two readings recorded this

• Vomiting (any grade)

  no effect, p = 0.31

  Vomiting | 1.22 (0.83-1.80) |.31

  PMID:37079302 · one of two readings recorded this

• CBD pharmacokinetic parameters Tmax, Cmax, AUC0-t, AUC0-inf and T1/2 in serum or plasma, random-effects multivariable meta-regression on dose, route, fed status and sex

  increases, higher CBD dose associated with higher Cmax, AUC0-t and AUC0-inf

  Not recorded as a finding: the compound is what was measured, not what was given

  A higher CBD dose was associated with higher Cmax, AUC0-t, and AUC0-inf.

  PMID:37643301 · one of two readings recorded this

• CBD serum/plasma Cmax, AUC0-t, AUC0-inf, Tmax and T1/2 in healthy adults, random-effects multivariable meta-regression on dose, route, formulation, fed status and sex

  increases

  Not recorded as a finding: this platform holds no node for the endpoint

  A higher CBD dose was associated with higher Cmax, AUC0-t, and AUC0-inf.

  PMID:37643301 · one of two readings recorded this

• Cmax and AUC0-t of CBD, fed versus fasting status

  increases

  Fed status was associated with higher Cmax and AUC0-t when compared with the fasting status

  PMID:37643301 · one of two readings recorded this

• Cmax, AUC0-t and AUC0-inf of CBD, oromucosal versus oral administration

  decreases

  Compared with oral administration, oromucosal administration was associated with lower Cmax, AUC0-t, and AUC0-inf

  PMID:37643301 · one of two readings recorded this

• Cmax of CBD, association with dose

  increases

  A higher CBD dose was associated with higher Cmax, AUC0-t, and AUC0-inf

  PMID:37643301 · one of two readings recorded this

• Tmax and Cmax of CBD, higher ratio of female participants

  modulates

  A higher ratio of female participants was associated with lower Tmax in oral administration and higher Cmax

  PMID:37643301 · one of two readings recorded this

• 100% reduction in MCSF (seizure-free), responder rate

  n = 45

  GWPCARE2 | CBD 10 mg/kg/day | 45 | 25/45 (55.6) | 16/45 (35.6) | 2/45 (4.4) | 10/44 (22.7) | 0/44 (0)

  PMID:38427284 · one of two readings recorded this

• 100% reduction in MCSF (seizure-free), responder rate

  n = 66

  GWPCARE2 | CBD 10 mg/kg/day | 66 | 29/66 (43.9) | 20/66 (30.3) | 2/66 (3.0) | 13/64 (20.3) | 0/64 (0)

  PMID:38427284 · one of two readings recorded this

• 100% reduction in MCSF (seizure-free), responder rate

  n = 40

  GWPCARE1B | CBD 20 mg/kg/day | 40 | 19/40 (47.5) | 10/40 (25.0) | 3/40 (7.5) | 8/40 (20.0) | 6/40 (15)

  PMID:38427284 · one of two readings recorded this

• 100% reduction in MCSF (seizure-free), responder rate

  n = 61

  GWPCARE1B | CBD 20 mg/kg/day | 61 | 26/61 (42.6) | 14/61 (23.0) | 3/61 (4.9) | 10/61 (16.4) | 8/61 (13.1)

  PMID:38427284 · one of two readings recorded this

• 100% reduction in MCSF (seizure-free), responder rate

  n = 40

  CBD 20 mg/kg/day | 40 | 25/40 (62.5) | 10/40 (25.0) | 2/40 (5) | 11/41 (26.8) | 4/41 (9.8)

  PMID:38427284 · one of two readings recorded this

• 100% reduction in MCSF (seizure-free), responder rate

  n = 67

  CBD 20 mg/kg/day | 67 | 33/67 (49.3) | 12/67 (17.9) | 3/67 (4.5) | 17/69 (24.6) | 5/69 (7.2)

  PMID:38427284 · one of two readings recorded this

• 100% reduction in MCSF (seizure-free), responder rate

  n = 40

  Study 1 | FFA 0.7 mg/kg/day (max 26 mg/day) | 40 | 27/40 (67.5) | 20/40 (50.0) | 3/40 (7.5) | 5/40 (12.5) | 5/40 (12.5)

  PMID:38427284 · one of two readings recorded this

• 100% reduction in MCSF (seizure-free), responder rate

  n = 49

  Study 3 | FFA 0.7 mg/kg/day (max 26 mg/day) | 49 | 35/49 (71.4) | 23/49 (46.9) | 6/49 (12.2) | 3/49 (6.1) | 2/49 (4.1)

  PMID:38427284 · one of two readings recorded this

• 100% reduction in MCSF (seizure-free), responder rate

  n = 41

  Placebo | 41 | 15/41 (36.6) | 4/41 (9.8) | 1/41 (2.4) | 7/41 (17.1) | 0/41 (0)

  PMID:38427284 · one of two readings recorded this

• 100% reduction in MCSF (seizure-free), responder rate

  n = 65

  Placebo | 65 | 17/65 (26.2) | 4/65 (6.2) | 1/65 (1.5) | 10/65 (15.4) | 0/65 (0)

  PMID:38427284 · one of two readings recorded this

• 100% reduction in MCSF (seizure-free), responder rate

  n = 21

  STICLO‐France | Stiripentol 50 mg/kg/day | 21 | 15/21 (71.5) | 12/21 (57.1) | 9/21 (42.9) | 2/21 (9.5) | 1/21 (4.8)

  PMID:38427284 · one of two readings recorded this

• 100% reduction in MCSF (seizure-free), responder rate

  n = 12

  STICLO‐Italy | Stiripentol 50 mg/kg/day | 12 | 8/12 (66.7) | 6/12 (50) | 3/12 (25) | 0/12 (0) | 1/12 (8.3)

  PMID:38427284 · one of two readings recorded this

• 100% reduction in MCSF (seizure-free), risk difference vs placebo

  no effect

  cannabidiol 10 mg/kg/day (non‐significant RD: 2% in the full trial population, and non‐significant RD: 3% in the subgroup taking clobazam)

  PMID:38427284 · one of two readings recorded this

• 100% reduction in MCSF (seizure-free), risk difference vs placebo

  no effect

  cannabidiol 10 mg/kg/day (non‐significant RD: 2% in the full trial population, and non‐significant RD: 3% in the subgroup taking clobazam)

  PMID:38427284 · one of two readings recorded this

• 100% reduction in MCSF (seizure-free), risk difference vs placebo

  increases

  cannabidiol 20 mg/kg/day (RD: 4%, NNT: 25 in the full trial population, and non‐significant RD: 5% in the subgroup taking clobazam)

  PMID:38427284 · one of two readings recorded this

• 100% reduction in MCSF (seizure-free), risk difference vs placebo

  no effect

  cannabidiol 20 mg/kg/day (RD: 4%, NNT: 25 in the full trial population, and non‐significant RD: 5% in the subgroup taking clobazam)

  PMID:38427284 · one of two readings recorded this

• 100% reduction in MCSF (seizure-free), risk difference vs placebo

  increases

  followed by fenfluramine (RD: 10%; NNT: 10)

  PMID:38427284 · one of two readings recorded this

• 100% reduction in MCSF (seizure-free), risk difference vs placebo

  increases

  stiripentol was the most effective of the three interventions, with a RD versus placebo of 36% and NNT of 3

  PMID:38427284 · one of two readings recorded this

• 100% responder rate, indirect risk difference STP vs FFA0_7 (full CBD populations)

  increases, p = 0.0047

  FFA0_7 | 0.26 [0.08; 0.44] | 0.0047 | FFA0_7

  PMID:38427284 · one of two readings recorded this

• >=50% reduction from baseline in monthly convulsive seizure frequency, responder proportion

  increases

  Not recorded as a finding: The sentence stating cannabidiol superior to placebo does not name the endpoint, so the object span cannot sit in the quote; node seizure-frequency-50-percent-responder-rate exists

  Stiripentol, fenfluramine, and cannabidiol were all statistically significantly superior to placebo.

  PMID:38427284 · one of two readings recorded this

• ≥50% reduction in MCSF, responder rate

  n = 45

  GWPCARE2 | CBD 10 mg/kg/day | 45 | 25/45 (55.6) | 16/45 (35.6) | 2/45 (4.4) | 10/44 (22.7) | 0/44 (0)

  PMID:38427284 · one of two readings recorded this

• ≥50% reduction in MCSF, responder rate

  n = 66

  GWPCARE2 | CBD 10 mg/kg/day | 66 | 29/66 (43.9) | 20/66 (30.3) | 2/66 (3.0) | 13/64 (20.3) | 0/64 (0)

  PMID:38427284 · one of two readings recorded this

The whole record — 347 rows