Children’s International Polyposis (CHIP) study: a randomized, double-blind, placebo-controlled study of celecoxib in children with familial adenomatous polyposis

Figures & data

Figure 1 Patient disposition.

Note: *Includes “Does not meet entrance criteria” and “Protocol violation”.
Abbreviation: ITT, intent-to-treat.

Table 1 Baseline patient characteristics (ITT population)

	Celecoxib (n=55)			Placebo (n=51)
	Female	Male	Total	Female	Male	Total
Sex, n (%)	29 (52.7)	26 (47.3)	55	28 (54.9)	23 (45.1)	51
Age
Mean (SD)	12.4 (2.3)	12.8 (2.0)	12.6 (2.2)	12.0 (1.7)	12.4 (2.0)	12.2 (1.8)
Range	10–17	10–17	10–17	10–15	10–17	10–17
Race, n (%)
White	26 (89.7)	20 (76.9)	46 (83.6)	21 (75.0)	19 (82.6)	40 (78.4)
Black	1 (3.4)	1 (3.8)	2 (3.6)	0	2 (8.7)	2 (3.9)
Asian	0	1 (3.8)	1 (1.8)	0	1 (4.3)	1 (2.0)
Other	2 (6.9)	4 (15.4)	6 (10.9)	7 (25.0)	1 (4.3)	8 (15.7)

Abbreviations: ITT, intent-to-treat; SD, standard deviation.

Figure 2 Time to disease progression (ITT population).

Note: Event defined as the appearance of >20 polyps that are >2 mm in size or diagnosis of colorectal malignancy.
Abbreviation: ITT, intent-to-treat.

Table 2 Total number of colorectal polyps (>2 mm in size) detected at annual colonoscopies findings (ITT population)

	Celecoxib (n=55)	Placebo (n=51)
Year 1
N	27	30
Mean (SD)	3.0 (2.68)	8.1 (7.32)
Median	2.0	6.0
Year 2
N	21	25
Mean (SD)	8.8 (6.63)	13.7 (10.51)
Median	6.0	11.0
Year 3
N	16	14
Mean (SD)	13.4 (11.31)	22.3 (11.74)
Median	10.0	20.0
Year 4
N	8	7
Mean (SD)	18.6 (17.65)	36.4 (22.50)
Median	11.5	32.0
Year 5
N	2	2
Mean (SD)	30.5 (21.92)	46.5 (34.65)
Median	30.5	46.5
Years 1–5 cumulatively
N	33	36
Mean (SD)	4.3 (3.58)	8.6 (7.12)
Median	3.0	7.0

Abbreviations: ITT, intent-to-treat; SD, standard deviation.

Table 3 Patients with AEs (safety population)*

	Celecoxib, n (%) (n=53)		Placebo, n (%) (n=48)
	All causes	Treatment related	All causes	Treatment related
Total AEs observed	270	43	226	43
Patients with any AE	40 (75.5)	18 (34.0)	35 (72.9)	15 (31.3)
Patients with serious AEs	3 (5.7)	0	0	0
Patients with severe AEs	5 (9.4)	1 (1.9)	3 (6.3)	0
Patients permanently discontinued study due to AEs	3 (5.7)	0	0	0
Patients permanently discontinued treatment due to AEs	6 (11.3)	4 (7.5)	1 (2.1)	1 (2.1)
Patients with dose reduction or temporary discontinuation due to AEs	19 (35.8)	4 (7.5)	12 (25.0)	2 (4.2)

Notes:

* Includes data up to 30 days after last dose of study drug. Except for the number of AEs, patients were counted only once per treatment in each row. Relationship of SAEs is displayed according to the investigator’s assessment.

Abbreviations: AE, adverse event; SAE, serious adverse event.

Table 4 AEs occurring in ≥10% of patients per group (safety population)

	Celecoxib, n (%) (n=53)	Placebo, n (%) (n=48)
Headache	16 (30.2)	14 (29.2)
Abdominal pain	9 (17.0)	10 (20.8)
Vomiting	9 (17.0)	9 (18.8)
Nausea	8 (15.1)	8 (16.7)
Cough	8 (15.1)	6 (12.5)
Abdominal discomfort	9 (17.0)	4 (8.3)
Oropharyngeal pain	6 (11.3)	5 (10.4)
Diarrhea	6 (11.3)	4 (8.3)
Fatigue	6 (11.3)	4 (8.3)
Nasopharyngitis	6 (11.3)	4 (8.3)
Upper respiratory tract infection	4 (7.5)	9 (18.8)
Influenza	6 (11.3)	1 (2.1)
Seasonal allergy	2 (3.8)	5 (10.4)

Abbreviation: AEs, adverse events.