Table 2.

Estimated incidence of adverse events.

	N	n	Incidence (95% CI)
Key adverse event indicators
Any AE	35	4,224	81.3 (77.5–85.1)
Grade 3 or higher AE	38	4,044	40.6 (35.7–45.5)
Serious AE	11	1,740	32.7 (22.4–43.1)
AE leading to discontinuation	33	4,146	28.3 (23.7–32.8)
Treatment-related death	38	4,272	0.7 (0.4–1.1)
Gastrointestinal
Aspartate aminotransferase	14	1,659	21.2 (14.9–27.5)
Alanine aminotransferase	14	1,659	18.1 (13.1–23.2)
Amylase	11	1,033	9.4 (6.2–12.7)
Lipase	15	2,457	11.9 (8.7–15.2)
Diarrhea	23	3,594	26.0 (21.5–30.5)
Colitis	16	2,053	8.2 (5.5–10.8)
Decreased appetite	15	2,792	12.1 (10.3–14.0)
Nausea	22	3,547	15.1 (12.1–18.1)
Vomiting	15	2,527	8.6 (5.9–11.4)
Dermatological
Rash	21	3,242	24.0 (19.3–28.7)
Maculopapular rash	12	1,877	12.4 (8.8–16.0)
Vitiligo	7	944	7.1 (5.3–8.8)
Pruritus	18	2,832	24.6 (20.3–28.8)
Hormonal
Hypothyroidism	20	3,190	13.1 (11.2–15.1)
Hyperthyroidism	15	1,701	11.0 (7.7–14.4)
Adrenal insufficiency	12	1,091	4.8 (2.8–6.7)
Hypopituitarism	6	335	9.5 (5.7–13.2)
Other adverse events
Fatigue	23	3,555	27.9 (22.6–33.3)
Pyrexia	17	1,282	14.8 (10.7–18.9)
Headache	11	1,035	13.5 (9.9–17.1)
Arthralgia	12	830	9.6 (6.5–12.7)
Pneumonitis	13	1,386	6.5 (5.1–7.9)

Incidence (95% CI), pooled incidence using random-model meta-analysis and its 95% CI. AE, adverse event; CI, confidence interval; N, number of populations; n, number of patients.