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Table 5 Frequently reported TEAEs (≥3% of patients in ≥1 treatment arm) in parts 2 and 3

From: An open-label phase 2 trial to assess the efficacy, safety and pharmacokinetics of lanthanum carbonate in hyperphosphatemic children and adolescents with chronic kidney disease undergoing dialysis

Category of TEAE

Safety analysis set 2 during part 2 of the studya

Safety analysis set 2 during part 2 and/or part 3 of the studya

CC

(n = 53)

LC

(n = 51)

LC

(n = 52)

n (%)

m

n (%)

m

n (%)

m

Any

28 (52.8)

63

28 (54.9)

56

41 (78.8)

124

Serious

9 (17.0)

10

11 (21.6)

17

19 (36.5)

29

Related to study drug

10 (18.9)

16

8 (15.7)

14

12 (23.1)

21

Leading to study withdrawal

2 (3.8)

2

3 (5.9)

6

3 (5.8)

6

Leading to death

0 (0.0)

0

0 (0.0)

0

0 (0.0)

0

TEAEs occurring in ≥3% of patients in ≥1 treatment arm

 Blood and lymphatic system disorders

  Anemia

0 (0.0)

0

0 (0.0)

0

2 (3.8)

2

 Gastrointestinal disorders

  Vomitingb

1 (1.9)

2

2 (3.9)

2

6 (11.5)

7

  Nauseac

2 (3.8)

2

2 (3.9)

3

4 (7.7)

6

  Abdominal pain

1 (1.9)

1

0 (0.0)

0

2 (3.8)

3

  Diarrhea

2 (3.8)

3

0 (0.0)

0

0 (0.0)

0

 General disorders and administration site conditions

  Pyrexia

0 (0.0)

0

1 (2.0)

1

2 (3.8)

3

 Infections and infestations

  Peritonitisd

0 (0.0)

0

3 (5.9)

4

5 (9.6)

6

  Upper respiratory tract infection

0 (0.0)

0

3 (5.9)

3

5 (9.6)

5

  Nasopharyngitis

2 (3.8)

2

0 (0.0)

0

2 (3.8)

3

  Device related infection

0 (0.0)

0

2 (3.9)

2

2 (3.8)

3

  Respiratory tract infection

3 (5.7)

5

0 (0.0)

0

2 (3.8)

2

  Hordeolum

0 (0.0)

0

1 (2.0)

1

2 (3.8)

2

  Influenza

2 (3.8)

2

0 (0.0)

0

1 (1.9)

1

Metabolism and nutrition disorders

 Hypercalcemiae

9 (17.0)

9

4 (7.8)

4

5 (9.6)

9

 Hypocalcemia

3 (5.7)

3

1 (2.0)

1

3 (5.8)

6

 Hyperkalemiae

1 (1.9)

1

0 (0.0)

0

2 (3.8)

2

 Hyperphosphatemia

2 (3.8)

2

0 (0.0)

0

0 (0.0)

0

 Hypophosphatemia

3 (5.7)

4

4 (7.8)

5

6 (11.5)

10

Vascular disorders

 Hypotension

0 (0.0)

0

2 (3.9)

4

2 (3.8)

4

 Hypertensiond

3 (5.7)

3

1 (2.0)

1

1 (1.9)

1

  1. Safety analysis set 2 included all patients who received at least one dose of CC or LC in part 2 and/or part 3 of the study and attended at least one follow-up visit. Reported TEAEs are stratified by treatment group and by system organ class and preferred term. Most TEAEs were considered by the investigator to be mild or moderate in severity, unless otherwise indicated
  2. TEAEs were categorized by the treatment most recently received by the patient and patients were counted once per category, per treatment group; adverse events were considered TEAEs if they occurred in the 3 weeks after the most recent dose of study drug within the relevant part of the study
  3. TEAEs were classified as severe in one LC-treated patient (2.0%) in part 2, and one LC-treated patient (1.9%) in parts 2 and 3 combined
  4. TEAEs were classified as severe in one LC-treated patient (2.0%) in part 2, and one LC-treated patient (1.9%) in parts 2 and 3 combined
  5. TEAEs were classified as severe in two LC-treated patients (3.9%) in part 2, and three LC-treated patients (5.8%) in parts 2 and 3 combined
  6. TEAEs were classified as severe in one CC-treated patient (1.9%) in part 2
  7. CC calcium carbonate, LC lanthanum carbonate, m the number of events experienced, TEAE treatment-emergent adverse event