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Table 4 Treatment-emergent adverse events in ≥ 2 subjects by system organ class

From: The effect of Lu AG09222 on PACAP38- and VIP-induced vasodilation, heart rate increase, and headache in healthy subjects: an interventional, randomized, double-blind, parallel-group, placebo-controlled study

 

Placebo + saline + saline

n = 5

Placebo + PACAP38 + VIP

n = 10

Lu AG09222 + PACAP38 + VIP

n = 10

Period 1a

 Feeling hot

2 (40.0)

0

0

 Headache

1 (20.0)

0

0

Period 2b

 Headache

4 (80.0)

9 (90.0)

4 (40.0)

 Feeling hot

0

10 (100)

3 (30.0)

 Flushing

0

10 (100)

1 (10.0)

 Palpitations

0

10 (100)

0

 Fatigue

2 (40.0)

2 (20.0)

2 (20.0)

 Musculoskeletal stiffness

0

3 (30.0)

1 (10.0)

 Disturbance in attention

1 (20.0)

0

2 (20.0)

 Nasal congestion

1 (20.0)

2 (20.0)

0

 Photosensitivity reaction

1 (20.0)

2 (20.0)

0

 Vomiting

0

2 (20.0)

0

Period 3c

 Headache

2 (40.0)

7 (70.0)

4 (40.0)

 Feeling hot

0

10 (100)

3 (30.0)

 Flushing

0

9 (90.0)

4 (40.0)

 Palpitations

0

6 (60.0)

0

 Fatigue

0

1 (10.0)

2 (20.0)

 Musculoskeletal stiffness

0

0

1 (10.0)

 Disturbance in attention

0

1 (10.0)

1 (10.0)

 Photosensitivity reaction

0

1 (10.0)

0

  1. AE Adverse event, PACAP38 Pituitary adenylate cyclase-activating polypeptide 38, VIP Vasoactive intestinal peptide
  2. aPeriod 1: AEs that started after dosing of the study drug (Lu AG09222 or placebo) but before PACAP38 or saline infusion
  3. bPeriod 2: AEs that started during or after the PACAP38 or saline infusion at visit 1, but before VIP or saline infusion at visit 2
  4. cPeriod 3: AEs that started during or after the VIP or saline infusion at visit 2