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Table 7 Summary of adverse events in the Rifampicin + FHND9041 group (SS)

From: Effect of CYP3A4 inhibitor and induction on the pharmacokinetics and safety of FHND9041, a novel EGFR T790M inhibitor, in healthy Chinese

System organ classification Preferred terminology

Monotherapy Phase with FHND9041

Monotherapy Phase with Rifampicin

Co-administration phase

Total

N

15

15

14

15

TEAE

9 (60.0%)[16]

2 (13.3%)[3]

4 (28.6%)[4]

10 (66.7%)[23]

Positive Urinary Occult Blood

0 (0.0%)[0]

0 (0.0%)[0]

2 (14.3%)[2]

2 (13.3%)[2]

Elevated Blood Myoglobin

0 (0.0%)[0]

0 (0.0%)[0]

2 (14.3%)[2]

2 (13.3%)[2]

C Elevated Reactive Proteins

1 (6.7%)[1]

0 (0.0%)[0]

0 (0.0%)[0]

1 (6.7%)[1]

Elevated Gamma-Glutamyltransferase

0 (0.0%)[0]

1 (6.7%)[1]

0 (0.0%)[0]

1 (6.7%)[1]

Elevated Alanine Aminotransferase

1 (6.7%)[1]

0 (0.0%)[0]

0 (0.0%)[0]

1 (6.7%)[1]

Elevated LDL

0 (0.0%)[0]

1 (6.7%)[1]

0 (0.0%)[0]

1 (6.7%)[1]

Decreased Lymphocyte Count

1 (6.7%)[1]

0 (0.0%)[0]

0 (0.0%)[0]

1 (6.7%)[1]

Positive Urine White Blood Cells

1 (6.7%)[1]

0 (0.0%)[0]

0 (0.0%)[0]

1 (6.7%)[1]

Elevated Blood Bilirubin

1 (6.7%)[1]

0 (0.0%)[0]

0 (0.0%)[0]

1 (6.7%)[1]

Hypertriglyceridemia

4 (26.7%)[4]

0 (0.0%)[0]

0 (0.0%)[0]

4 (26.7%)[4]

Hyperuricaemia

2 (13.3%)[2]

0 (0.0%)[0]

0 (0.0%)[0]

2 (13.3%)[2]

Hypercholesterolaemia

0 (0.0%)[0]

1 (6.7%)[1]

0 (0.0%)[0]

1 (6.7%)[1]

Upper Respiratory Tract Infection

1 (6.7%)[1]

0 (0.0%)[0]

0 (0.0%)[0]

1 (6.7%)[1]

Have A High Temperature

1 (6.7%)[1]

0 (0.0%)[0]

0 (0.0%)[0]

1 (6.7%)[1]

Haematuria

1 (6.7%)[1]

0 (0.0%)[0]

0 (0.0%)[0]

1 (6.7%)[1]

Oral Mucositis

1 (6.7%)[1]

0 (0.0%)[0]

0 (0.0%)[0]

1 (6.7%)[1]

Anemic

1 (6.7%)[1]

0 (0.0%)[0]

0 (0.0%)[0]

1 (6.7%)[1]

  1. Note: All adverse events are coded using the MedDRA version 26.0 (Chinese) coding system and are presented in the form of number of cases (percentage) [cases]