Table 2.

Estimated incidence of adverse events.

Adverse event	N	n	Incidence (95% CI)
Key adverse event indicators
Any AE	19	1788	77.8 (67.9–87.6)
Grade 3 or higher AE	21	1865	29.3 (24.2–34.4)
Serious AE	24	2536	34.9 (28.1–41.7)
AE leading to discontinuation	22	1977	13.3 (9.3–17.4)
Treatment-related death	28	2605	0.98 (0.45–1.5)
Gastrointestinal
Aspartate aminotransferase	18	1332	8.3 (5.5–11.2)
Alanine aminotransferase	18	1560	10.6 (6.8–14.4)
Amylase	18	1349	7.0 (4.1–9.9)
Lipase	20	1569	7.0 (4.3–9.7)
Diarrhea	30	2720	21.7 (17.8–25.6)
Colitis	18	1677	3.9 (2.1–5.7)
Decreased appetite	20	2354	17.9 (13.7–22.0)
Nausea	25	2383	15.9 (12.1–19.6)
Vomiting	21	2118	10.8 (7.8–14.0)
Dermatological
Rash	27	2357	14.8 (11.4–18.3)
Maculopapular rash	9	326	9.9 (3.8–16.1)
Vitiligo	4	201	0.5 (0–2.9)
Pruritus	29	2669	17.9 (14.4–21.3)
Hormonal
Hypothyroidism	22	1965	9.6 (7.6–11.6)
Hyperthyroidism	14	1319	4.3 (2.9–5.7)
Adrenal insufficiency	14	1510	0.7 (0.06–1.3)
Hypopituitarism	7	1122	0.3 (0.2–0.8)
Other adverse events
Fatigue	30	2740	30.1 (23.8–36.3)
Pyrexia	18	1708	12.1 (9.1–15.2)
Headache	14	916	5.7 (3.4–8.0)
Arthralgia	18	1177	7.2 (3.7–11.0)
Pneumonitis	23	1666	2.3 (1.5–3.2)

Incidence (95% CI), pooled incidence using random model meta-analysis and its 95% confidence interval.

AE, adverse event; NA, not available; N, number of populations; n, number of patients.